Back to resultsLumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement
Primary Purpose
Hip Osteoarthritis, Pain, Acute, Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
lumbar plexus block
suprainguinal fascia iliaca block
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring nerve block, fascia iliaca, hip replacement, lumbar plexus
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 80 years
- American Society of Anesthesiologists classification 1-3
- Body mass index between 20 and 35 (kg/m2)
Exclusion Criteria:
- Adults who are unable to give their own consent
- Pre-existing neuropathy (assessed by history and physical examination)
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- Allergy to local anesthetics (LAs) or morphine
- Pregnancy
- Prior surgery in the corresponding side of the lumbar o suprainguinal area
- Chronic pain syndromes requiring opioid intake at home
Sites / Locations
- Hospital Clínico Universidad de Chile
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lumbar plexus block
Suprainguinal fascia iliaca block
Arm Description
Patients randomized to receive an ultrasound-guided lumbar plexus block
Patients randomized to receive an ultrasound-guided suprainguinal fascia iliaca block
Outcomes
Primary Outcome Measures
Morphine consumption over 24 hours
Total morphine consumption over 24 hours post block
Secondary Outcome Measures
Performance time
Interval between the start of skin disinfection and the end of local anesthetic injection
Number of needle passes
The initial needle insertion counted as the first pass. Any subsequent needle advancement that is preceded by a retraction of at least 10 mm counts as an additional pass
Postoperative static pain at 3 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative static pain at 6 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative static pain at 12 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative static pain at 24 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative dynamic pain at 3 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative dynamic pain at 6 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative dynamic pain at 12 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative dynamic pain at 24 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative static pain at 48 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative dynamic pain at 48 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time until first morphine demand
Time until first patient-controlled analgesia morphine demand
Block assessment at 3 hours
Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.
Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.
Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Block assessment at 6 hours
Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.
Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.
Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Block assessment at 24 hours
Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.
Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.
Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Incidence of block related adverse events
Incidence of adverse events related to nerve block (vascular puncture, local anesthetic systemic toxicity, epidural spread)
Incidence of opioid related adverse events
Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression)
Incidence of Inability to perform physiotherapy
Inability to perform physiotherapy due to pain (score more than 4 in Numeric Rating Score from 0 to 10 points) or motor blockade.
Surgical duration
Time between skin incision and closure
Readiness to discharge
Days to be ready for discharge following physiotherapist criteria
Length of hospital stay
Length of hospital stay after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03744065
Brief Title
Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement
Official Title
A Randomized Comparison Between Ultrasound Guided Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The nerves from lumbar plexus (LP) are the current target to achieve analgesia after a total hip arthroplasty (THA). Lumbar plexus block (LPB) is an alternative that provides optimal postoperative analgesia. However, many adverse effects and complications have been reported due to its proximity to vital structures. Because of these shortcomings, an alternative to block the LP nerves is required.
In a recent trial suprainguinal Fascia Iliaca Block (SFIB) was reported to provide reliable analgesia in THA. SFIB may carry a lower risk profile, however, no study has compared the efficacy of LPB and SFIB in this setting.
Thus, this randomized trial is set out to compare US guided LPB and SFIB for analgesia after THA. The hypothesis is that both blocks would result in similar postoperative opioid (morphine) consumption at 24 hours and, therefore, designed the study as an equivalence trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Pain, Acute, Pain, Postoperative, Opioid Use
Keywords
nerve block, fascia iliaca, hip replacement, lumbar plexus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lumbar plexus block
Arm Type
Active Comparator
Arm Description
Patients randomized to receive an ultrasound-guided lumbar plexus block
Arm Title
Suprainguinal fascia iliaca block
Arm Type
Experimental
Arm Description
Patients randomized to receive an ultrasound-guided suprainguinal fascia iliaca block
Intervention Type
Procedure
Intervention Name(s)
lumbar plexus block
Intervention Description
Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, in the posteromedial quadrant of psoas muscle
Intervention Type
Procedure
Intervention Name(s)
suprainguinal fascia iliaca block
Intervention Description
Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, underneath the fascia iliaca at the suprainguinal level
Primary Outcome Measure Information:
Title
Morphine consumption over 24 hours
Description
Total morphine consumption over 24 hours post block
Time Frame
24 hours post block
Secondary Outcome Measure Information:
Title
Performance time
Description
Interval between the start of skin disinfection and the end of local anesthetic injection
Time Frame
2 hours after surgery
Title
Number of needle passes
Description
The initial needle insertion counted as the first pass. Any subsequent needle advancement that is preceded by a retraction of at least 10 mm counts as an additional pass
Time Frame
2 hours after surgery
Title
Postoperative static pain at 3 hours after block
Description
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time Frame
3 hours after the block
Title
Postoperative static pain at 6 hours after block
Description
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time Frame
6 hours after the block
Title
Postoperative static pain at 12 hours after block
Description
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time Frame
12 hours after the block
Title
Postoperative static pain at 24 hours after block
Description
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time Frame
24 hours after the block
Title
Postoperative dynamic pain at 3 hours after block
Description
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time Frame
3 hours after the block
Title
Postoperative dynamic pain at 6 hours after block
Description
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time Frame
6 hours after the block
Title
Postoperative dynamic pain at 12 hours after block
Description
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time Frame
12 hours after the block
Title
Postoperative dynamic pain at 24 hours after block
Description
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time Frame
24 hours after the block
Title
Postoperative static pain at 48 hours after block
Description
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time Frame
48 hours after the block
Title
Postoperative dynamic pain at 48 hours after block
Description
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time Frame
48 hours after the block
Title
Time until first morphine demand
Description
Time until first patient-controlled analgesia morphine demand
Time Frame
48 hours after the block
Title
Block assessment at 3 hours
Description
Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.
Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.
Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Time Frame
3 hours after the block
Title
Block assessment at 6 hours
Description
Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.
Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.
Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Time Frame
6 hours after the block
Title
Block assessment at 24 hours
Description
Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.
Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.
Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Time Frame
24 hours after the block
Title
Incidence of block related adverse events
Description
Incidence of adverse events related to nerve block (vascular puncture, local anesthetic systemic toxicity, epidural spread)
Time Frame
3 hours after block
Title
Incidence of opioid related adverse events
Description
Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression)
Time Frame
48 hours after block
Title
Incidence of Inability to perform physiotherapy
Description
Inability to perform physiotherapy due to pain (score more than 4 in Numeric Rating Score from 0 to 10 points) or motor blockade.
Time Frame
24 hours after the block
Title
Surgical duration
Description
Time between skin incision and closure
Time Frame
4 hours
Title
Readiness to discharge
Description
Days to be ready for discharge following physiotherapist criteria
Time Frame
4 days after surgery
Title
Length of hospital stay
Description
Length of hospital stay after surgery
Time Frame
7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 80 years
American Society of Anesthesiologists classification 1-3
Body mass index between 20 and 35 (kg/m2)
Exclusion Criteria:
Adults who are unable to give their own consent
Pre-existing neuropathy (assessed by history and physical examination)
Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
Allergy to local anesthetics (LAs) or morphine
Pregnancy
Prior surgery in the corresponding side of the lumbar o suprainguinal area
Chronic pain syndromes requiring opioid intake at home
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Bravo, MD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universidad de Chile
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8380456
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17961837
Citation
Siddiqui ZI, Cepeda MS, Denman W, Schumann R, Carr DB. Continuous lumbar plexus block provides improved analgesia with fewer side effects compared with systemic opioids after hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):393-8. doi: 10.1016/j.rapm.2007.04.008.
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Citation
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Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement
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